Vectical Ointment

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Effects on Calcium Metabolism

In controlled clinical trials with VECTICAL (calcitriol ointment) Ointment, among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle. However, the increases in calcium and albumin-adjusted calcium levels were less than 10% above the upper limit of normal.

If aberrations in parameters of calcium metabolism occur, treatment should be discontinued until these parameters have normalized. The effects of VECTICAL (calcitriol ointment) Ointment on calcium metabolism following treatment durations greater than 52 weeks have not been evaluated. Increased absorption may occur with occlusive use.

Ultraviolet Light Exposure

Animal data suggest that the vehicle of VECTICAL (calcitriol ointment) Ointment may enhance the ability of ultraviolet radiation (UVR) to induce skin tumors [see Carcinogenesis, Mutagenesis, Impairment of Fertility]

Subjects who apply VECTICAL (calcitriol ointment) Ointment to exposed skin should avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning booths and sun lamps. Physicians may wish to limit or avoid use of phototherapy in patients who use VECTICAL (calcitriol ointment) Ointment.

Unevaluated Uses

The safety and effectiveness of VECTICAL (calcitriol ointment) Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated.

The safety and effectiveness of VECTICAL (calcitriol ointment) Ointment in patients with erythrodermic, exfoliative, or pustular psoriasis have not been evaluated.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

When calcitriol was applied topically to mice for up to 24 months, no significant changes in tumor incidence were observed. Concentrations of calcitriol in ointment base of 0 (vehicle control), 0.3, 0.6 and 1.0 ppm were evaluated.

A two-year carcinogenicity study was conducted in which calcitriol was orally administered to rats at dosages of approximately 0.005, 0.03, and 0.1 mcg/kg/day (0.03, 0.18, and 0.6 mcg/m²/day, respectively). The incidence of benign pheochromocytomas was significantly increased in female rats. No other significant differences in tumor incidence data were observed.

In a study in which albino hairless mice were exposed to both ultra-violet radiation (UVR) and topically applied calcitriol ointment, a reduction in the time required for UVR to induce the formation of skin tumors was observed in all groups that received the ointment base, including the vehicle-treated control group, relative to animals that received no ointment but which were exposed to UVR. The time required for UVR to induce the formation of skin tumors did not differ between animals that received plain vehicle and those that received vehicle that contained calcitriol. Concentrations of calcitriol in ointment base of 0 (vehicle control), 0.3, 0.6 and 1.0 ppm were evaluated. These data suggest that the vehicle of VECTICAL (calcitriol ointment) Ointment may enhance the ability of UVR to induce skin tumors.

Calcitriol did not elicit genotoxic effects in the mouse lymphoma TK locus assay. Studies in which male and female rats received oral doses of calcitriol of up to 0.6 mcg/kg/day (3.6 mcg/m²/day) indicated no impairment of fertility or general reproductive performance. Based upon the recommended human dose and instructions for use, it is not possible to calculate human dose equivalents for animal exposure in these studies.

Use In Specific Populations

Pregnancy

Teratogenic Effects: Pregnancy Category C.

VECTICAL Ointment contains calcitriol which has been shown to be fetotoxic. There are no adequate and well-controlled studies for VECTICAL (calcitriol ointment) Ointment in pregnant women. VECTICAL (calcitriol ointment) Ointment should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.

Teratogenicity studies with calcitriol were performed in which rats were treated orally at dosages up to 0.9 mcg/kg/day (5.4 mcg/m²/day) and in which rabbits received topical application of calcitriol ointment (3 ppm) to 6.4% of the body surface area. No effects on reproductive or fetal parameters were observed in rats. In rabbits, topically applied calcitriol induced a significantly elevated mean post-implantation loss and an increased incidence of minor skeletal abnormalities due to retarded ossification of the pubic bones. A slightly increased incidence of skeletal variation (extra 13thrib, reduced ossification of epiphyses) was also observed. These effects may have been secondary to maternal toxicity. Based on the recommended human dose and instructions for use, it is not possible to calculate human dose equivalents for animal exposures in these studies.

Nursing Mothers

It is not known whether calcitriol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VECTICAL (calcitriol ointment) Ointment is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of VECTICAL (calcitriol ointment) Ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported experience has not identified differences in responses between the elderly and younger patients.

Last reviewed on RxList: 3/10/2009
This monograph has been modified to include the generic and brand name in many instances.

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